This is a phase 2, double-blind, randomized, placebo-controlled, multi-center, dose-finding study to evaluate the efficacy and safety of Kylo-11 administered subcutaneously compared to placebo in participants with ASCVD and elevated Lp(a).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
Administered subcutaneously
Percent change from baseline in time-averaged Lp(a) over Weeks 8~26
A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.
Time frame: Baseline, Weeks 8~26
Percent change from baseline in time-averaged Lp(a) over Weeks 38~52
A MMRM including terms of treatment arm, stratification factors, scheduled visit and the interaction of treatment arm with scheduled visit will be used to estimate the percent change from baseline in time-averaged Lp(a) over Weeks 8\~26. The least squares means (LS means) by treatment arm and the treatment difference (Kylo-11 - placebo) based on the model will be summarized.
Time frame: Baseline, Weeks 38~52
Proportion of participants achieving Lp(a) <125 nmol/L and <75 nmol/L at Week 26 and Week 52
For proportion of participants achieving Lp(a) \<125 nmol/L and \<75 nmol/L at Week 26 and Week 52, the number of responders in both the Kylo-11 arm and the placebo arm will be calculated separately.
Time frame: Week 26 and Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Baotou Medical College
Baotou, China
RECRUITINGBeijing Anzhen Hospital
Beijing, China
RECRUITINGBeijing Chao-Yang Hospital, Capital Medical University
Beijing, China
RECRUITINGChina-Japan Union Hospital of Jilin University
Changchun, China
NOT_YET_RECRUITINGThe First People's Hospital of Changde
Changde, China
NOT_YET_RECRUITINGThe Third Xiangya Hospital of Central South University
Changsha, China
NOT_YET_RECRUITINGSichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, China
NOT_YET_RECRUITINGChongqing University Three Gorges Hospital
Chongqing, China
RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
NOT_YET_RECRUITING...and 33 more locations